Apparatus and methods for receiving discharged urine

ABSTRACT

A system suitable for collecting and transporting urine away from the body of a person or animal may include an assembly having a fluid impermeable casing, a fluid permeable membrane, and a fluid permeable support. A reservoir is defined by the fluid permeable support. The fluid permeable membrane can define a cavity. The casing can define an opening such that the cavity is accessible via the opening. The assembly can also include an outlet in fluidic communication with the reservoir. The assembly can be arranged such that a user&#39;s penis can be disposed through the opening with the urethral opening disposed within the cavity and such that a fluid can flow into the body from the urethral opening of the user&#39;s penis, collect in the reservoir, and flow out of the outlet.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to and thebenefit of U.S. patent application Ser. No. 15/612,325, filed Jun. 2,2017, entitled “Apparatus and Methods for Receiving Discharged Urine,which application is a continuation-in-part of and claims priority toand the benefit of U.S. patent application Ser. No. 15/221,106, filedJul. 27, 2016, entitled “Male Urine Collection Device Using WickingMaterial,” and also a continuation-in-part of and claims priority to andthe benefit of U.S. patent application Ser. No. 15/238,427, filed Aug.16, 2016, entitled “Using Wicking Material to Collect Urine From a Malefor Transport,” the disclosures of all of which are incorporated hereinby reference in their entirety.

TECHNICAL FIELD

The present disclosure relates generally to systems, apparatus, andmethods for collecting and transporting urine away from the body of aperson or animal.

BACKGROUND

The embodiments described herein relate generally to collecting andtransporting urine away from the body of a person or animal. In variouscircumstances, a person or animal may have limited or impaired mobilitysuch that typical urination processes are challenging or impossible. Forexample, a person may experience or have a disability that impairsmobility. A person may have restricted travel conditions such as thoseexperienced by pilots, drivers, and workers in hazardous areas.Additionally, sometimes urine collection is needed for monitoringpurposes or clinical testing.

Urinary catheters, such as a Foley catheter, can be used to address someof these circumstances, such as incontinence. Unfortunately, however,urinary catheters can be uncomfortable, painful, and can lead tocomplications, such as infections. Additionally, bed pans, which arereceptacles used for the toileting of bedridden patients, such as thosein a health care facility, are sometimes used. Bed pans, however, can beprone to discomfort, spills, and other hygiene issues.

Males who suffer the most severe consequences of urinary incontinence,such as discomfort, rashes, and sores are typically elderly and oftenbedbound. They also require continuous assistance to maintain hygiene.Characteristics often found in these patients: they typically lay ontheir back, the size of the penis often decreases with age, skin rollscontaining fat tissue cause the penis to recede, often pointing upwardwhile in a laying position, patients have difficulty reaching the penisand manipulating devices. A urine capture device should be designed withreference to these characteristics.

Available solutions are typically for use while standing up (such ascups and funnels), with a urine discharge port opposite to the distalend of the penis. Other designs such as condom-style catheters aredifficult for patients to manipulate, too often they are dimensionallyincompatible; and they do not stay on reliably.

Thus, there is a need for a device capable of collecting urine from aperson or animal, particularly a male, comfortably and with minimalcontamination of the user and/or the surrounding area.

SUMMARY

A system is disclosed that is suitable for collecting and transportingurine away from the body of a person or animal, particularly a male. Thedisclosed system includes an assembly that may include a fluidimpermeable casing, a fluid permeable support, a fluid permeablemembrane, and a tube. The fluid impermeable casing can define anopening, an interior region, and a fluid outlet. The fluid permeablesupport can define a reservoir. The support can be disposed within theinterior region. The fluid permeable membrane can be disposed on thesupport and cover at least a portion of the support. The fluid permeablemembrane can at least partially define a cavity. The tube can have afirst end disposed in the elongated reservoir and can extend through thefluid outlet to a second, fluid discharge end. The apparatus isconfigured to be disposed with a user's penis disposed through theopening and with the urethral opening of the penis disposed within thecavity, to receive urine discharged from the urethral opening throughthe membrane, the support, and into the reservoir, and to have thereceived urine withdrawn from the reservoir via the tube and out of thefluid discharge end of the tube.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram of a system, according to anembodiment.

FIG. 2 is a top view of an assembly, according to an embodiment.

FIG. 3 is a cross-sectional view of the assembly of FIG. 2 taken alongline 3-3 of FIG. 2 .

FIG. 4 is a flowchart illustrating a method of using an assembly tocollect urine from a user, according to an embodiment.

FIG. 5 is a schematic block diagram of a system, according to anembodiment.

FIG. 6 is a top view of an assembly, according to an embodiment.

FIG. 7 is a cross-sectional view of the assembly of FIG. 5 taken alongline 7-7 of FIG. 5 .

FIG. 8 is a flowchart illustrating a method of using an assembly tocollect urine from a user, according to an embodiment.

DETAILED DESCRIPTION

A system is disclosed that is suitable for collecting and transportingurine away from the body of a person or animal, particularly a male. Insome embodiments, the disclosed system includes an apparatus that mayinclude a fluid impermeable casing, a fluid permeable support, a fluidpermeable membrane, and a tube. The fluid impermeable casing can definean opening, an interior region, and a fluid outlet. The fluid permeablesupport can define a reservoir. The support can be disposed within theinterior region. The fluid permeable membrane can be disposed on thesupport and cover at least a portion of the support. The fluid permeablemembrane can at least partially define a cavity. The tube can have afirst end disposed in the elongated reservoir and can extend through thefluid outlet to a second, fluid discharge end. The apparatus isconfigured to be disposed with a user's penis disposed through theopening and with the urethral opening of the penis disposed within thecavity, to receive urine discharged from the urethral opening throughthe membrane, the support, and into the reservoir, and to have thereceived urine withdrawn from the reservoir via the tube and out of thefluid discharge end of the tube.

In some embodiments, a method includes disposing in operativerelationship with the urethral opening of a male user, a urinecollecting apparatus. The method can include disposing in operativerelationship with the urethral opening of a male user a urine collectingapparatus. The urine collecting apparatus can include a fluidimpermeable casing, a fluid permeable support, a fluid permeablemembrane, and a tube. The fluid impermeable casing can define anopening, an interior region, and a fluid outlet. The fluid permeablesupport can define a reservoir. The support can be disposed within theinterior region. The fluid permeable membrane can be disposed on thesupport and can cover at least the portion of the support. The fluidpermeable membrane can at least partially define a cavity. The tube canhave a first end disposed in the elongated reservoir and extendingthrough the fluid outlet to a second, fluid discharge end. The operativerelationship can include the user's penis being disposed through theopening in the casing with the urethral opening of the penis disposedwithin the cavity. Urine discharged from the urethral opening can beallowed to be received through the membrane, the support, and into thereservoir. The received urine can be withdrawn from the reservoir viathe tube and out of the fluid discharge end of the tube.

In some embodiments, an apparatus can include a fluid impermeablecasing, a fluid permeable support, a fluid permeable membrane, and atube. The fluid impermeable casing can define an opening, an interiorregion, and a fluid outlet. The fluid permeable support can be disposedwithin the interior region and have a first side facing the opening anda second side opposite the first side. The second side and the casingcan collectively define a reservoir between the second side and thecasing. The fluid permeable membrane can be disposed on the supportbetween the opening and the first side of the support. The fluidpermeable membrane and the casing can collectively define a cavity. Thetube can have a first end disposed in the reservoir and can extendthrough the fluid outlet to a second, fluid discharge end. The apparatuscan be configured to be disposed with a user's penis disposed throughthe opening with the urethral opening of the penis disposed within thecavity, to receive urine discharged from the urethral opening throughthe membrane, the support, and into the reservoir, and to have thereceived urine withdrawn from the reservoir via the tube and out of thefluid discharge end of the tube.

In some embodiments, a method can include disposing in operativerelationship with the urethral opening of a male user a urine collectingapparatus. The urine collecting apparatus can include a fluidimpermeable casing, a fluid permeable support, a fluid permeablemembrane, and a tube. The fluid impermeable casing can define anopening, an interior region, and a fluid outlet. The fluid permeablesupport can be disposed within the interior region and have a first sidefacing the opening and a second side opposite the first side. The secondside and the casing can collectively defining a reservoir between thesecond side and the casing. The fluid permeable membrane can be disposedon the support between the opening and the first side of the support.The fluid permeable membrane and the casing can collectively defining acavity. The tube can have a first end disposed in the reservoir and canextend through the fluid outlet to a second, fluid discharge end. Theoperative relationship can include the user's penis being disposedthrough the opening in the casing with the urethral opening of the penisdisposed within the cavity. Urine discharged from the urethral openingcan be allowed to be received through the membrane, the support, andinto the reservoir. The received urine can be allowed to be withdrawnfrom the reservoir via the tube and out of the fluid discharge end ofthe tube.

In some embodiments, a device can be used to so collect urine flowingfrom the penis of a person or an animal in such a manner that the urinecan be readily transported from the device as the urine is beingcollected. The device can include a chamber assembly in which wickingmaterial is disposed about porous material that is configured to form achamber in which urine can be collected for transport. The chamber canhave a port for receiving a tube so that urine collected within thechamber can be transported from the chamber by being drawn from thechamber when a partial vacuum is applied within the chamber via saidreceived tube. The chamber assembly can be so dimensioned and configuredthat opposing portions of the assembly can be sufficiently adjacent asto define an opening through the which the head of a penis can beinserted. A layer of impermeable material can be so attached to thechamber assembly as to cover one side of the opening and thereby providea receptacle for receiving the head of said inserted penis. Urineflowing from said penis can be drawn from the receptacle through thewicking material and the porous material into the chamber when saidpartial vacuum is applied within the chamber via said tube.

In some embodiments, a device can be used to so collect urine flowingfrom the penis of a person or an animal in such a manner that the urinecan be transported from the device as the urine is being collected. Thedevice can include a flexible layer of porous material, a flexiblewicking material disposed on one side of the layer of porous material,and a flexible layer of impermeable material. The flexible layer ofimpermeable material can be secured to the periphery of the other sideof the layer of porous material and so cover the other side of the layerof porous material as to define a chamber between the layer of porousmaterial and the layer of impermeable material, within which chamberurine can be collected for transport. The chamber can have a port forreceiving a tube so that urine collected within the chamber can betransported from the chamber by being drawn from the chamber when apartial vacuum is applied within the chamber via said received tube. Thecombination of the wicking material, the layer of porous material, andthe layer of impermeable material can be so dimensioned and configuredas to provide a receptacle for receiving the head of a penis. Urineflowing from said penis can be drawn from the receptacle through thewicking material and the porous material into the chamber when saidpartial vacuum is applied within the chamber via said received tube.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials, or a combination thereof.

The embodiments described herein can be formed or constructed of one ormore biocompatible materials. Examples of suitable biocompatiblematerials include metals, ceramics, or polymers. Examples of suitablemetals include pharmaceutical grade stainless steel, gold, titanium,nickel, iron, platinum, tin, chromium, copper, and/or alloys thereof.Examples of polymers include nylons, polyesters, polycarbonates,polyacrylates, polymers of ethylene-vinyl acetates and other acylsubstituted cellulose acetates, non-degradable polyurethanes,polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulphonate polyolefins, polyethylene oxide,polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and/orblends and copolymers thereof.

FIG. 1 is a schematic block diagram of a system 100. The system 100includes an assembly 102. The assembly 102 includes a permeable membrane130, a permeable support 140, and an impermeable casing 150 (alsoreferred to herein as an “impermeable layer”). The permeable membrane130 and the permeable support 140 can also be collectively referred toas a “chamber assembly.” The permeable support 140 defines a reservoir110 (also referred to herein as a “chamber”). The assembly 102 alsoincludes an outlet 120 (also referred to herein as a “port”) in fluidiccommunication with the reservoir 110. The permeable support 140 and thepermeable membrane 130 can be arranged such that the permeable membrane130 defines a cavity 152. The impermeable casing 150 defines an opening132 such that the cavity 152 is accessible from the exterior of theassembly 100. The impermeable casing 150 can direct fluid toward thereservoir 110 and/or reduce and/or prevent fluid from exiting theassembly 102 except via the outlet 120. In some implementations, theassembly 102 can be arranged such that a fluid can flow through theopening 132, into the cavity 152, through the permeable membrane 130,through the permeable support 140, into the reservoir 110, and out ofthe outlet 120. In some implementations, the assembly 102 can bearranged such that a user's penis can be inserted through the opening132 such that the user's urethral opening is disposed within the cavity152 and a fluid can flow from the user's urethral opening, into thecavity 152, through the permeable membrane 130, through the permeablesupport 140, into the reservoir 110, and out of the outlet 120. In someimplementations, the system 100 can include a discharge line 122 (alsoreferred to herein as a “received tube”). The discharge line 122 can befluidically coupled to an external receptacle 160. The externalreceptacle 160 can be in fluidic communication with a vacuum source 170via a vacuum line 124. The discharge line 122 and the vacuum line 124can both include flexible tubing, such as, for example, flexible plastictubing.

More specifically, the impermeable casing 150 can define an interiorregion accessible via the opening 132. The permeable membrane 130 andthe permeable support 140 (and thus, the reservoir 110) can be disposedwithin the interior region of the impermeable casing 150. Theimpermeable casing 150 can be any suitable shape. For example, in someimplementations, the impermeable casing 150 can be bowl-shaped. In someimplementations, the impermeable casing 150 can include a bottom surfaceand at least one sidewall. In some implementations, the at least onesidewall can define the opening 132 such that the opening 132 isopposite the bottom surface of the impermeable casing 150 and theinterior region of the impermeable casing 150 is bounded (andcollectively defined) by the bottom surface, the sidewall, and theopening 132. In some implementations, the impermeable casing 150includes a top surface and the top surface defines the opening 132opposite the bottom surface. In some implementations, the sidewall ofthe impermeable casing 150 is curved and continuous such that theimpermeable casing 150 has a round (e.g., circular or ovalular)perimeter. In some implementations, the impermeable casing 150 can haveany suitable shape and/or perimeter, such as the shape of an oblong, asquare, or a triangle. In some implementations, the one or moresidewalls can be concave such that the one or more sidewalls can receiveat least a portion of the permeable membrane 130 and the permeablesupport 140 as described in more detail below.

In some implementations, the impermeable casing 150 can be disposedaround only a portion of the exterior sides of the permeable membrane130 and/or the permeable support 140. In some implementations, theimpermeable casing 150 can cover all of the exterior sides of thechamber assembly (i.e., the permeable membrane 130 and/or permeablesupport 140). In some implementations, the impermeable casing 150 can bedisposed such that the impermeable casing 150 can wrap around theexterior surface of the permeable membrane 130 and/or the permeablesupport 140 and cover a portion of the interior side or sides of thechamber assembly (i.e., the permeable membrane 130 and/or the permeablesupport 140). In some implementations, the permeable membrane 130 andthe permeable support 140 can be arranged to define a passageway withopen ends (e.g., as a ring), and the impermeable casing 150 can beapplied to one end and a side of the chamber assembly (i.e., thepermeable membrane 130 and the permeable support 140) such that a cavity152 is defined with the open end and the closed end. In someimplementations, the chamber assembly can define the opening 132 ratherthan the impermeable casing 150. In some implementations, the portion ofthe impermeable casing 150 closing one end of the cavity 152 andpartially defining the cavity 152 can have any suitable shape such thata portion or all of the head of a user's penis can be disposed withinthe cavity 152. For example, the portion of the impermeable casing 150closing one end of the cavity 152 can be curved, convex, or flat.

In some implementations, the impermeable casing 150 can be attached tothe chamber assembly (i.e., the permeable membrane 130 and the permeablesupport 140) via an adhesive. In some implementations, the impermeablecasing 150 can be attached to the chamber assembly via any suitableretention mechanism, such as, for example, retainer clips or otherfasteners. In some implementations, the impermeable casing 150 can bepreshaped and the chamber assembly can be inserted into the impermeablecasing 150 and retained in a particular shape by the impermeable casing150. In some implementations, the impermeable casing 150 can be formedby, for example, elongate strips of adhesive tape such that theimpermeable casing 150 can maintain the chamber assembly in theconfiguration defining the cavity 152.

The impermeable layer 150 can be impermeable to fluid, such as, forexample, urine. In some implementations, the impermeable layer 150 canhave a fluid transportation function and can assist in directing fluidtowards the reservoir 110 and/or through the outlet 120 of the reservoir110. In some implementations, the impermeable layer 150 can be formed asan integral, unitary structure. In other implementations, theimpermeable layer 150 can be a multi-piece structure. The impermeablelayer 150 can be a pre-molded (e.g., injection or blow molded)component. Alternatively, the impermeable layer 150 can be formed of amaterial, such as elongate strips of an adhesive tape, wrapped around atleast a portion of the reservoir 110, a portion of the permeable support140, and/or a portion of the permeable membrane 130. In someembodiments, the impermeable layer 150 can be formed of cardboard,pressed paper, and/or coated paper. In some embodiments, the impermeablelayer 150 can be flexible.

The permeable membrane 130 can be formed of a material that haspermeable properties with respect to liquids such as urine. Thepermeable properties can be wicking, capillary action, diffusion, orother similar properties or processes, and are referred to herein as“permeable” and/or “wicking.” The permeable membrane 130 can have a highabsorptive rate and a high permeation rate such that urine can berapidly absorbed by the permeable membrane 130 and/or transportedthrough the permeable membrane 130. In some implementations, thepermeable membrane 130 can be flexible. In some implementations, thepermeable membrane 130 can be a ribbed knit fabric. In someimplementations, the permeable membrane 130 can be shaped as a tubularsleeve such that the permeable membrane 130 can be disposed around thepermeable support 140. In some implementations, the permeable membrane130 can include and/or have the moisture-wicking characteristic ofgauze, felt, terrycloth, thick tissue paper, and/or a paper towel. Insome implementations, the permeable membrane 130 can be soft and/orminimally abrasive such that the permeable membrane 130 does notirritate the skin of the user. The permeable membrane 130 can beconfigured to wick fluid away from the urethral opening and/or the skinof the user such that the dampness of the skin of the user is lessenedand infections are prevented. Additionally, the wicking properties ofthe permeable membrane 130 can help prevent urine from leaking orflowing beyond the assembly (e.g., out of opening 132) onto, forexample, a bed. In some implementations, the permeable membrane 130 canbe formed of fine denier polyester fibers coated with a thermoplasticwater-based binder system. The tensile strength can be, for example,about 45 lbs/inch² (measured using an Instron test method). The weightof a permeable membrane can be, for example, about 12 grams (measuredusing the Mettler Gram Scale). The thickness per ten permeable membranescan be, for example, about 2.5″ (measured using theGustin-Bacon/Measure-Matic).

The permeable support 140 can be positioned relative to the permeablemembrane 130 such that the permeable support 140 maintains the permeablemembrane 130 in a particular shape and allows for fluid, such as, forexample, urine, to flow through the permeable membrane 130, through thepermeable support 140, and into the reservoir 110. In someimplementations, the permeable support 140 can be ring-shaped such that,when disposed within the impermeable casing 150, the cavity 152 isdefined in the center of the ring-shaped permeable support 140. Saidanother way, an outer surface of the permeable support 140 on the innerportion of the “ring” can define the cavity 152. When the permeablemembrane 130 is disposed on the permeable support 140, the permeablemembrane 130 can define a portion of the boundaries of the cavity 152.When the permeable support 140 and the permeable membrane 130 aredisposed within the impermeable casing 150, the cavity 152 can bealigned with the opening 132 of the impermeable casing 150. Thereservoir 110 can be defined within or by the permeable support 140 suchthat the reservoir 110 is an elongated, ring-shaped reservoir.

In some implementations, the permeable support 140 can be shaped and/orformed as a complete or continuous ring or circle. In someimplementations, the permeable support 140 can be shaped and/or formedas a partial circle and/or in a discontinuous C-shape with spaced ends.In some implementations, the permeable support 140 can be U-shaped. Insome implementations, the chamber assembly can be dimensioned andconfigured such that opposing end portions of the chamber assembly aresufficiently adjacent or proximate as to define an opening through whichthe head of a penis can be inserted. In some implementations, thepermeable support 140 can be formed of a bendable tube having two ends.The bendable tube can be arranged such that the two ends meet (e.g.,forming a C-shape) and the permeable support 140 can be secured suchthat the permeable support 140 has a substantially circular shape. Insome implementations, the outlet or port 120 can be positioned at theintersection of the two ends and in fluid communication with theelongated ring-shaped reservoir 110 defined by the permeable support140. The discharge line 122 can be inserted through the outlet 120 (andthus through the impermeable casing 150 and the permeable support 140)and into fluid communication with the reservoir 110.

In some implementations, the permeable support 140 can be formed as anelongated tube such that the reservoir 110 extends through a portion orthrough the entire length of the elongated tube. The permeable support140 can then be arranged and/or bent to form a ring such that thepermeable support 140 defines the cavity 152 in the center of the ring.In some implementations, the inner diameter or other dimensions of thepermeable support 140 can be sized such that the cavity 152 can receivea penis of a user such that a head of the penis can be partially orfully disposed within the cavity 152 when the penis is disposed withinthe opening 132 of the impermeable casing 150. Said another way, theshaft of the penis can be disposed within the opening 132 and the headof the penis can be fully disposed within the cavity 152, or theurethral opening of the head of the penis can be disposed within thecavity 152 and the head can be partially disposed within the cavity 152and partially outside the cavity 152, with the opening 132 surrounding aportion of the head. In some implementations, the cavity 152 can bedimensioned to receive a head of a penis of a user such that urine canbe received from the urethral opening of the penis within the cavity152, by the permeable membrane 130, and/or by the permeable support 140without urine splashing out of the opening 132.

In some implementations, the permeable support 140 can be configured tomaintain the permeable membrane 130 against the skin of a penis of auser and/or near a urethral opening of a user. For example, thepermeable support 140 can be shaped and sized such that the cavity 152is slightly larger than a head or tip of a penis of a user. Thepermeable support 140 can include a portion having a curved or convexshape in contact with the permeable membrane 130 such that the permeablemembrane 130 is also curved or convex. The permeable support 140 cansupport the permeable membrane 130 such that the permeable membrane 130can rest against the skin of the head or tip of the penis with theurethral opening directed toward a bottom surface of the impermeablecasing 150, and thus creating a comfortable and at least partiallyenclosed interface for engagement with the area of the body (e.g., thehead and/or neck of a penis of a user) near the urethral opening.

In some implementations, the permeable support 140 can be made of arigid plastic. In some implementations, the permeable support 140 canhave any suitable shape and be formed of any suitable material. Forexample, the permeable support 140 can be flexible. Additionally, thepermeable support 140 can be formed of aluminum, a composite of plasticand aluminum, some other metal and/or a composite of plastic and anothermetal. In some implementations, the permeable support 140 can be formedof a natural material, such as, for example, plant fibers (e.g., GreenerClean manufactured by 3M®). The natural material can include openingsthat allow fluid to flow through the natural material. In someembodiments, the permeable support 140 can be cylindrical and can definea lumen. In some embodiments, the permeable support 140 can be formed ofperforated coated paper, such as tubular waxed paper.

The permeable support 140 can define one or more openings (e.g., anarray of openings) to allow for fluid flow from the permeable membrane130 to the reservoir 110. In some implementations, the permeable support140 can be formed as a curved tube or a curved cylinder with one or moreopenings. In some implementations, the permeable support 140 can includemembrane supports (e.g., struts) extending across an opening such thatthe opening is divided into an array of distinct slot-shaped openings.The membrane supports can be used to support the permeable membrane 130.For example, the membrane supports can maintain the shape of thepermeable membrane 130 against the skin of a penis of a user and/or neara urethral opening of a user such that urine flowing from the urethralopening contacts and travels through the permeable membrane 130. In someimplementations, the permeable support 140 can define several openingshaving a variety of shapes, such as a plurality of round openings. Insome implementations, the permeable support 140 can be formed as acurved or ring-shaped cylinder of spun plastic (e.g., non-wovenpermeable nylon and polyester webbing) such that the permeable support140 can have many openings. For example, a rectangular portion of spunplastic can be folded or rolled into a cylinder shape and then curvedinto a ring or U-shape for use in the assembly 102. In someimplementations, the permeable support 140 can be formed of a porousmaterial. For example, the permeable support 140 can be a porous glassring-shaped tubular container defining frits. In other implementations,the permeable support 140 can define an opening in a sidewall of thepermeable support 140 and the sidewall can be covered by a mesh screendefining many smaller openings. In some embodiments, the reservoir 110can include any spaces and/or openings defined within the permeablesupport 140 (e.g., spaces within porous material or defined within spunplastic material).

The reservoir 110 can be any suitable shape and/or have any diameter (orother dimension) suitable for receiving and transporting urine duringuse of the system 100. In some implementations, the reservoir 110 can besized such that the reservoir 110 is capable of collecting andtemporarily holding a large or small amount of urine until the urine canbe removed from the reservoir via the outlet 120. For example, thereservoir 110 can be sized such that the reservoir 110 is configured tohold a small amount of urine as may be released due to incontinence. Insome implementations, the reservoir 110 can be sized such that thereservoir 110 is configured to hold a large amount of urine as may bereleased during voiding of a full bladder. In some implementations, thereservoir 110 can be sized such that the reservoir is configured tocollect and hold a small or large amount of urine while the urine issimultaneously removed via, for example, gravity and/or a pump, such asthe vacuum source 170. Said another way, the reservoir 110 can functionas a sump and be sized such that the reservoir 110 can form a portion ofa passageway for urine from the permeable membrane 130, through thepermeable support 140, through the reservoir 110, and out of the outlet120. In a condition where the flow rate of urine into the assembly 102via the permeable membrane 130 is greater than the flow rate of urinethrough the discharge line 122, a temporary backup of urine may occur inthe reservoir 110. Thus, the reservoir 110 can be sized to contain avolume of fluid that may temporarily accumulate due to the difference inflow rates into and out of the assembly 102. Although the outlet 120 isshown as extending from the side of the reservoir 110, in someimplementations, the outlet 120 can extend from the bottom of thereservoir 110.

In some embodiments, the assembly 102 can optionally include a cushionassembly 180. The cushion assembly 180 can include a membrane layer 182and a support layer 184 (also referred to herein as a “bed of porousmaterial”). The membrane layer 182 can be formed of the same or asimilar material as the permeable membrane 130 and can have the same orsimilar properties as the permeable membrane 130. For example, themembrane layer 182 can be configured to wick fluid (e.g., urine) awayfrom a urethral opening of a user when a urethral opening of a user isposition near or in contact with the membrane layer 182. The membranelayer 182 can also be permeable such that fluid (e.g., urine) can flowthrough the membrane layer 182 and to the permeable membrane 130 and/orthe permeable support 140, into the reservoir 110, and through theoutlet 120. The support layer 184 can be formed of the same or a similarmaterial as the permeable support 140 and can have the same or similarproperties as the permeable support 140. For example, the support layer184 can be configured to maintain the membrane layer 182 near or incontact with the head of a user's penis when the head of the user'spenis is disposed within the cavity 152 of the assembly 102. The supportlayer 184 can also be permeable such that fluid (e.g., urine) can flowthrough the membrane layer 182, through the support layer 184, and tothe permeable membrane 130 and/or the permeable support 140, into thereservoir 110, and through the outlet 120. The cushion assembly 180 canbe arranged within the impermeable casing 150 such that the cushionassembly 180 forms a boundary of the cavity 152 (e.g., the bottom of thecavity 152). The cushion assembly 180 can be positioned along a bottomsurface of the impermeable casing 150 such that a user's penis can beplaced in contact with the cushion assembly 180 and/or such that urineflowing from a user's urethral opening into the cavity 152 can flow intothe cushion assembly 180 thereby reducing splashing. In someimplementations, the cushion assembly 180 (and specifically the membranelayer 182) can be disposed within the impermeable casing 150 such thatthe cushion assembly 180 contacts the permeable membrane 130.

The external receptacle 160, via the discharge line 122, can collectfluid exiting the reservoir 110 through the outlet 120. The externalreceptacle 160 can be a sealed container. In some implementations, theexternal receptacle 160 can be disposable. In some implementations, theexternal receptacle 160 can be configured to be sterilized and reused.

In some implementations, gravity can cause fluid within the reservoir110 to follow a flow path (i.e., the fluid flow path including theoutlet 120 and the discharge line 122) from the reservoir 110 to theexternal receptacle 160. In some implementations, the vacuum source 170can assist and/or provide the pressure differential needed to draw fluidvoided from the urethral opening of a user into the permeable support140, into the reservoir 110, and from the reservoir 110 into theexternal receptacle 160. The vacuum source 170 can be fluidicallycoupled to the external receptacle 160 via a vacuum line 124 such thatgaseous fluid is drawn from the external receptacle 160 via the vacuumline 124. As a result of the decrease in pressure within the externalreceptacle 160 caused by the drawing of gaseous fluid out of theexternal receptacle 160, liquid and/or gaseous fluid can be drawn fromthe reservoir 110, through the outlet 120, through the discharge line122, and into the external receptacle 160. In some implementations, thevacuum source 170 can apply sufficient suction to capture all orsubstantially all of the urine voided by a user in a variety ofpositions (e.g., when a male user is lying on his side or back).

The vacuum source 170 can have a sufficiently high vacuum strength andair volume transport rate such that rapid air and liquid aspiration ismaintained over a portion of or the entire permeable membrane 130. Insome implementations, the one or more openings of the permeable support140 are distributed over an area that is slightly larger than the areaof the permeable membrane 130 that is configured to be wetted by urineflow in operation. Thus, the partial vacuum created by the vacuum source170 in combination with the one or more openings of the permeablesupport 140 and the permeable membrane 130 can draw the urine contactingthe permeable membrane 130 into the assembly 102 and, specifically, intothe reservoir 110. In some implementations, however, the one or moreopenings of the permeable support 140 should not be distributed over toolarge of an area of the permeable support 140 because the partial vacuumstrength may be reduced, thereby reducing the urine collection rate andthe efficiency of the system 100.

In some implementations, the vacuum source 170 can be a pump that isreadily available, inexpensive, relatively quiet, and/or configured torun continuously. For example, the vacuum source 170 can be an aquariumaerator pump. The vacuum line 124 can be attached to the intake port ofthe aquarium aerator pump (rather than the exhaust port of the aerator)such that gaseous fluid is drawn into the aquarium aerator pump from theexternal receptacle 160 via the vacuum line 124. In someimplementations, the necessary static vacuum of the system 100 is about3-10 feet of water (10%-30% of one atmosphere; 80-250 mm Hg) with afree-flow rate of about 10-100 cubic centimeters per second. In someimplementations, the necessary static vacuum of the system 100 is higheror lower depending on the size of the user and the expected rate ofurine flow from the user and/or through the system 100. In someimplementations, the discharge line 122 can be about 0.25″ in diameterand the vacuum source 170 can be configured to cause about 500 cubiccentimeters of urine to flow through the discharge line 122 to theexternal receptacle 160 over the duration of a typical urination eventfor a user, which may typically range from 10 to 20 seconds but may beshorter or longer, e.g., 5 to 90 seconds. In some implementations, thevacuum source 170 can include a wall-mounted vacuum system, such as isfound in hospitals. In some implementations, a wall-mounted vacuumsystem can be configured to apply a vacuum of, for example, about 20 mmHg to about 40 mm Hg. In some implementations, the vacuum source 170 canbe powered by electrical AC or DC power. For example, in mobileapplications when the user is away from an AC power source, such as whenthe user is using the system 100 during transportation via a wheel chairor motor vehicle, the vacuum source 170 can be powered by DC power.

In some implementations, urine collected by any of the systems and/orassemblies described herein can be sampled for analysis using urinestrips. Urine test strips can be used to test a variety of healthmeasures. Urine test strips can be configured to change color inresponse to being wetted with urine to indicate a particular measurement(i.e., the colors can correspond to known measurement scales). In someimplementations, a urine test strip (not shown) can be inserted into thedischarge line 122 such that urine flowing from the outlet 120 to theexternal receptacle 160 contacts the urine test strip. The dischargeline 122 can be transparent such that data on the urine test strip canbe read through a wall of the discharge line 122. In someimplementations, the urine test strip can be disposed within theexternal receptacle 160 such that urine flowing into the externalreceptacle 160 contacts the urine test strip. The external receptacle160 can be at least partially transparent such that the urine test stripcan be read through a wall of the external receptacle 160.

In some implementations, a camera, such as a camera built into aportable communication device (e.g., a smartphone, an iPhone, or thelike) can be used to read the data on the urine test strip. The cameracan capture an image of the test strip and the image can be processedusing, for example, a smartphone application. The data read from theurine test strip can be sent to a clinician for analysis and/or sent toa cloud-based address for physician access.

In some implementations, the system 100 can include a scale (not shown).For example, the scale can be disposed underneath the externalreceptacle 160 such that the scale is configured to measure the weightof fluid (e.g., urine) in the external receptacle 160. The dataindicating the weight of the fluid that has been delivered to theexternal receptacle 160 via the discharge line 122 can be measured atdifferent time intervals and processed to determine how much urine, forexample, has been voided by a user of the system 100.

Although described as being intended for use by an adult male, in someimplementations the system 100 can be used in adult, pediatric, male,female, and veterinary applications for animals of different species andsizes. In female applications, the assembly 102 can be placed betweenthe legs or labia of the user and held snugly against the externalurethra by the pressure of friction from the user's body, by thepressure of the legs or by such means as an undergarment, elasticstrips, and/or adhesive tape. In male applications, the assembly 102 canbe placed such that a penis of a user is disposed within the assembly102 (e.g., within the cavity 152 formed within the assembly 102). A maleuser can use the assembly 102 in any suitable position, such as, forexample, while lying on his back, lying on his side, sitting, orstanding. In some implementations, the head of the penis of the maleuser can be placed in contact with the permeable membrane 130 and/or themembrane layer 182 during urination. In some implementations, the headof the penis of the male user can be disposed at least partially withinthe cavity 452, but not placed in contact with the permeable membrane430 and/or the membrane layer 182 during urination.

FIG. 2 is a top view of an assembly 202. FIG. 3 is a cross-sectionalview of the assembly 202 taken along line 3-3 in FIG. 2 . The assembly202 includes a permeable membrane 230, a permeable support 240, and acushion assembly 280. The permeable membrane 230 and the permeablesupport 240 can also be collectively referred to as a “chamberassembly.” The permeable membrane 230, the permeable support 240, andthe cushion assembly 280 are disposed within an impermeable casing (alsoreferred to herein as an “impermeable layer”). The permeable membrane230, the permeable support 240, the cushion assembly 280, and theimpermeable casing 250 can be the same or similar in structure and/orfunction to the permeable membrane 130, the permeable support 140, thecushion assembly 180, and the impermeable casing 150 described abovewith reference to the system 100. For example, the permeable support 240defines a reservoir 210 (also referred to herein as a “channel”). Theimpermeable casing 250 defines an opening 232 (also referred to hereinas a “port”). The assembly 202 also includes an outlet 220 in fluidiccommunication with the reservoir 210.

The permeable support 240 and the permeable membrane 230 can be arrangedsuch that the permeable support 240 and/or the permeable membrane 230collectively define a cavity 252 within the permeable membrane 230. Theimpermeable casing 250 can direct fluid toward the reservoir 210 and/orreduce and/or prevent fluid from exiting the assembly 202 except via theoutlet 220. In some implementations, the assembly 202 can be arrangedsuch that a fluid can flow through the opening 232, into the cavity 252,through the permeable membrane 230, through the permeable support 240,into the reservoir 210, and out of the outlet 220. In someimplementations, the assembly 202 can be arranged such that a user'spenis can be inserted through the opening 232 such that the user'surethral opening is disposed within the cavity 252 and a fluid can flowfrom the user's urethral opening, into the cavity 252, through thepermeable membrane 230, through the permeable support 240, into thereservoir 210, and out of the outlet 220. A discharge line 222 (e.g., atube) (also referred to herein as a “received tube”) can extend throughthe outlet 220. A first end (not shown) of the discharge line 222 can bepositioned within the reservoir 210, and the discharge line 222 canextend through the permeable support 240, the permeable membrane 230,and the impermeable casing 250 such that fluid in the reservoir 210 canbe transported away from the assembly 202 via the discharge line 222. Asecond end of the discharge line 222 can be fluidically coupled to anexternal receptacle (e.g., external receptacle 160). The externalreceptacle can be in fluidic communication with a vacuum source (e.g.,vacuum source 170) via a vacuum line (e.g., vacuum line 124). Thedischarge line 222 and the vacuum line can both include flexible tubing,such as, for example, flexible plastic tubing.

More specifically, the impermeable casing 250 can define an interiorregion accessible via the opening 232. The permeable membrane 230 andthe permeable support 240 (and thus, the reservoir 210) can be disposedwithin the interior region of the impermeable casing 250. Theimpermeable casing 250 can be any suitable shape. For example, in someimplementations, the impermeable casing 250 can be bowl-shaped. As shownin FIG. 3 , the impermeable casing 250 can include a bottom surface anda sidewall. The sidewall can define the opening 232 such that theopening 232 is opposite the bottom surface of the impermeable casing 250and the interior region of the impermeable casing 250 is bounded (andcollectively defined) by the bottom surface, the sidewall, and theopening 232. The sidewall of the impermeable casing 250 can be curvedand continuous such that the impermeable casing 250 has a round (e.g.,circular or ovalular) perimeter. The sidewall can be concave such thatthe one or more sidewalls can receive at least a portion of thepermeable membrane 230 and the permeable support 240 as shown in FIG. 3.

The impermeable layer 250 can be impermeable to fluid, such as, forexample, urine. In some implementations, the impermeable layer 250 canhave a fluid transportation function and can assist in directing fluidtowards the reservoir 210 and/or through the outlet 220 of the reservoir210. In some implementations, the impermeable layer 250 can be formed asan integral, unitary structure. In other implementations, theimpermeable layer 250 can be a multi-piece structure. The impermeablelayer 250 can be a pre-molded (e.g., injection or blow molded)component. Alternatively, the impermeable layer 250 can be formed of amaterial, such as elongate strips of an adhesive tape, wrapped around atleast a portion of the reservoir 210, a portion of the permeable support240, and/or a portion of the permeable membrane 230. In someembodiments, the impermeable layer 250 can be formed of cardboard,pressed paper, and/or coated paper. In some embodiments, the impermeablelayer 250 can be flexible.

The permeable membrane 230 can be formed of a material that haspermeable properties with respect to liquids such as urine. Thepermeable properties can be wicking, capillary action, diffusion, orother similar properties or processes, and are referred to herein as“permeable” and/or “wicking.” The permeable membrane 230 can have a highabsorptive rate and a high permeation rate such that urine can berapidly absorbed by the permeable membrane 230 and/or transportedthrough the permeable membrane 230. In some implementations, thepermeable membrane 230 can be flexible. In some implementations, thepermeable membrane 230 can be a ribbed knit fabric. In someimplementations, the permeable membrane 230 can be shaped as a tubularsleeve such that the permeable membrane 230 can be disposed around thepermeable support 240. In some implementations, the permeable membrane230 can include and/or have the moisture-wicking characteristic ofgauze, felt, terrycloth, thick tissue paper, and/or a paper towel. Insome implementations, the permeable membrane 230 can be soft and/orminimally abrasive such that the permeable membrane 230 does notirritate the skin of the user. The permeable membrane 230 can beconfigured to wick fluid away from the urethral opening and/or the skinof the user such that the dampness of the skin of the user is lessenedand infections are prevented. Additionally, the wicking properties ofthe permeable membrane 230 can help prevent urine from leaking orflowing beyond the assembly (e.g., out of opening 232) onto, forexample, a bed. In some implementations, the permeable membrane 230 canbe formed of fine denier polyester fibers coated with a thermoplasticwater-based binder system. The tensile strength can be, for example,about 45 lbs/inch² (measured using an Instron test method). The weightof a permeable membrane can be, for example, about 12 grams (measuredusing the Mettler Gram Scale). The thickness per ten permeable membranescan be, for example, about 2.5″ (measured using theGustin-Bacon/Measure-Matic).

The permeable support 240 can be positioned relative to the permeablemembrane 230 such that the permeable support 240 maintains the permeablemembrane 230 in a particular shape and allows for fluid, such as, forexample, urine, to flow through the permeable membrane 230, through thepermeable support 240, and into the reservoir 210. As shown in FIG. 2 ,the permeable support 240 can be ring-shaped such that, when thepermeable membrane 230 is disposed on the permeable support 240 and thepermeable support 240 is disposed within the impermeable casing 250, thecavity 252 is defined in the center of the ring-shaped permeable support240 and permeable membrane 230. Said another way, an outer surface ofthe permeable membrane 230 on the inner portion of the “ring” can definethe cavity 252. As shown in FIGS. 2 and 3 , the cavity 252 can bealigned with the opening 232 of the impermeable casing 250. Thereservoir 210 can be defined within the permeable support 240 such thatthe reservoir 210 is an elongated, ring-shaped reservoir.

In some implementations, the permeable support 240 can be shaped and/orformed as a complete or continuous ring or circle. In someimplementations, the permeable support 240 can be shaped and/or formedas a partial circle. In some implementations, the chamber assembly canbe dimensioned and configured such that opposing end portions of thechamber assembly are sufficiently adjacent or proximate as to define anopening through which the head of a penis can be inserted. In someimplementations, the permeable support 240 can be formed of a bendabletube having two ends. The bendable tube can be arranged such that thetwo ends meet (e.g., forming a C-shape) and the permeable support 240can be secured such that the permeable support 240 has a substantiallycircular shape. In some implementations, the outlet or port 220 can bepositioned at the intersection of the two ends and in fluidcommunication with the elongated ring-shaped reservoir 210 defined bythe permeable support 240. The discharge line 222 can be insertedthrough the outlet 220 (and thus through the impermeable casing 250 andthe permeable support 240) and into fluid communication with thereservoir 210.

In some implementations, the permeable support 240 can be formed as anelongated tube such that the reservoir 210 extends through a portion orthrough the entire length of the elongated tube. The permeable support240 can then be arranged and/or bent to form a ring such that thepermeable support 240 defines the cavity 252 in the center of the ring.In some implementations, the inner diameter or other dimensions of thepermeable support 240 can be sized such that the cavity 252 can receivea penis of a user such that a head of the penis can be partially orfully disposed within the cavity when the penis is disposed within theopening 232 of the impermeable casing 250. Said another way, the shaftof the penis can be disposed within the opening 232 and the head of thepenis can be fully disposed within the cavity 252, or the urethralopening of the head of the penis can be disposed within the cavity 252and the head can be partially disposed within the cavity 252 andpartially outside the cavity 252, with the opening 232 surrounding aportion of the head. In some implementations, the cavity 252 can bedimensioned to receive a head of a penis of a user such that urine canbe received from the urethral opening of the penis within the cavity252, by the permeable membrane 230, and/or by the permeable support 240without urine splashing out of the opening 232.

In some implementations, the permeable support 240 can be configured tomaintain the permeable membrane 230 against the skin of a penis of auser and/or near a urethral opening of a user. For example, thepermeable support 240 can be shaped and sized such that the cavity 252is slightly larger than a head or tip of a penis of a user. Thepermeable support 240 can include a portion having a curved or convexshape in contact with the permeable membrane 230 such that the permeablemembrane 230 is also curved or convex. The permeable support 240 cansupport the permeable membrane 230 such that the permeable membrane 230can rest against the skin of the head or tip of the penis with theurethral opening directed toward a bottom surface of the impermeablecasing 250, and thus creating a comfortable and at least partiallyenclosed interface for engagement with the area of the body (e.g., thehead and/or neck of a penis of a user) near the urethral opening.

In some implementations, the permeable support 240 can be made of arigid plastic. In some implementations, the permeable support 240 canhave any suitable shape and be formed of any suitable material. Forexample, the permeable support 240 can be flexible. Additionally, thepermeable support 240 can be formed of aluminum, a composite of plasticand aluminum, some other metal and/or a composite of plastic and anothermetal. In some implementations, the permeable support 240 can be formedof a natural material, such as, for example, plant fibers (e.g., GreenerClean manufactured by 3M®). The natural material can include openingsthat allow fluid to flow through the natural material. In someembodiments, the permeable support 240 can be cylindrical and can definea lumen. In some embodiments, the permeable support 240 can be formed ofperforated coated paper, such as tubular waxed paper.

The permeable support 240 can define one or more openings (e.g., anarray of openings) to allow for fluid flow from the permeable membrane230 to the reservoir 210. In some implementations, the permeable support240 can be formed as a curved tube or a curved cylinder with one or moreopenings. In some implementations, the permeable support 240 can includemembrane supports (e.g., struts) extending across an opening such thatthe opening is divided into an array of distinct slot-shaped openings.The membrane supports can be used to support the permeable membrane 230.For example, the membrane supports can maintain the shape of thepermeable membrane 230 against the skin of a penis of a user and/or neara urethral opening of a user such that urine flowing from the urethralopening contacts and travels through the permeable membrane 230. In someimplementations, the permeable support 240 can define several openingshaving a variety of shapes, such as a plurality of round openings. Insome implementations, the permeable support 240 can be formed as acurved or ring-shaped cylinder of spun plastic (e.g., non-wovenpermeable nylon and polyester webbing) such that the permeable support240 can have many openings. For example, a rectangular portion of spunplastic can be folded or rolled into a cylinder shape and then curvedinto a ring for use in the assembly 202. In some implementations, thepermeable support 240 can be formed of a porous material. For example,the permeable support 240 can be a porous glass ring-shaped tubularcontainer defining frits. In other implementations, the permeablesupport 240 can define an opening in a sidewall of the permeable support240 and the sidewall can be covered by a mesh screen defining manysmaller openings. In some embodiments, the reservoir 210 can include anyspaces and/or openings defined within the permeable support 240 (e.g.,spaces within porous material or defined within spun plastic material).

The reservoir 210 can be any suitable shape and/or have any diameter (orother dimension) suitable for receiving and transporting urine duringuse of a system including the assembly 202. In some implementations, thereservoir 210 can be sized such that the reservoir 210 is capable ofcollecting and temporarily holding a large or small amount of urineuntil the urine can be removed from the reservoir via the outlet 220.For example, the reservoir 210 can be sized such that the reservoir 210is configured to hold a small amount of urine as may be released due toincontinence. In some implementations, the reservoir 210 can be sizedsuch that the reservoir 210 is configured to hold a large amount ofurine as may be released during voiding of a full bladder. In someimplementations, the reservoir 210 can be sized such that the reservoiris configured to collect and hold a small or large amount of urine whilethe urine is simultaneously removed via, for example, gravity and/or apump, such as the vacuum source 270. Said another way, the reservoir 210can function as a sump and be sized such that the reservoir 210 can forma portion of a passageway for urine from the permeable membrane 230,through the permeable support 240, through the reservoir 210, and out ofthe outlet 220. In a condition where the flow rate of urine into theassembly 202 via the permeable membrane 230 is greater than the flowrate of urine through the discharge line 222, a temporary backup ofurine may occur in the reservoir 210. Thus, the reservoir 210 can besized to contain a volume of fluid that may temporarily accumulate dueto the difference in flow rates into and out of the assembly 202.

Although the outlet 220 is shown as extending from the side of thereservoir 210, in some implementations, the outlet 220 can extend fromthe bottom of the reservoir 210.

The cushion assembly 280 can include a membrane layer 282 and a supportlayer 284 (also referred to herein as a “bed of porous material”). Themembrane layer 282 can be formed of the same or a similar material asthe permeable membrane 230 and can have the same or similar propertiesas the permeable membrane 230. For example, the membrane layer 282 canbe configured to wick fluid (e.g., urine) away from a urethral openingof a user when a urethral opening of a user is position near or incontact with the membrane layer 282. The membrane layer 282 can also bepermeable such that fluid (e.g., urine) can flow through the membranelayer 282 and to the permeable membrane 230 and/or the permeable support240, into the reservoir 210, and through the outlet 220. The supportlayer 284 can be formed of the same or a similar material as thepermeable support 240 and can have the same or similar properties as thepermeable support 240. For example, the support layer 284 can beconfigured to maintain the membrane layer 282 near or in contact withthe head of a user's penis when the head of the user's penis is disposedwithin the cavity 252 of the assembly 202. The support layer 284 canalso be permeable such that fluid (e.g., urine) can flow through themembrane layer 282, through the support layer 284, and to the permeablemembrane 230 and/or the permeable support 240, into the reservoir 210,and through the outlet 220. The cushion assembly 280 can be arrangedwithin the impermeable casing 250 such that the cushion assembly 280forms a boundary of the cavity 252 (e.g., the bottom of the cavity 252).The cushion assembly 280 can be positioned along a bottom surface of theimpermeable casing 250 such that a user's penis can be placed in contactwith the cushion assembly 280 and/or such that urine flowing from auser's urethral opening into the cavity 252 can flow into the cushionassembly 280 thereby reducing splashing. In some implementations, thecushion assembly 280 (and specifically the membrane layer 282) can bedisposed within the impermeable casing 250 such that the cushionassembly 280 contacts the permeable membrane 230.

FIG. 4 is a flowchart illustrating a method of using an assembly tocollect urine from a user, according to an embodiment. The method 300optionally includes, at 302, fluidically coupling a discharge end of atube of a urine collecting apparatus to a fluid receptacle. The method300 optionally further includes, at 304, fluidically coupling thedischarge end of the tube of the urine collecting apparatus to a sourceof vacuum.

The method 300 further includes, at 306, disposing the urine collectingapparatus in operative relationship with the urethral opening of theuser, with a head of a penis of a male user (e.g. human or animal)disposed through an opening and into a cavity at least partially definedby a membrane of the urine collecting apparatus. The urine collectingapparatus can be the same or similar in structure and/or function to anyof the urine collecting apparatus described herein, such as, forexample, the assembly 102 in FIG. 1 and/or the assembly 202 in FIG. 2 .For example, the urine collecting apparatus can include a fluidimpermeable casing, a fluid permeable support, a fluid permeablemembrane, and a tube. The fluid impermeable casing can define anopening, an interior region, and a fluid outlet. The fluid permeablesupport can define a reservoir. The fluid permeable support can also bedisposed within the interior region of the fluid impermeable casing. Thefluid permeable membrane can be disposed on the support and cover atleast a portion of the support. The fluid permeable membrane can atleast partially define a cavity aligned with the opening defined in thefluid impermeable casing. The tube can have a first end disposed in theelongated reservoir and extend through the fluid outlet to a second,fluid discharge end. The assembly can be arranged such that a fluid canflow into the cavity from the urethral opening of the user's penis, flowthrough the fluid permeable membrane and the fluid permeable support,collect in the reservoir, and flow out of the outlet.

The method 300 also includes, at 308, allowing urine discharged from thepenis to be received into the cavity, through the membrane, through thesupport, and into the reservoir.

The method 300 also includes, at 310, allowing the received urine to bewithdrawn from the reservoir via the tube and out of the fluid dischargeend of the tube.

The method 300 optionally includes, at 312, allowing the withdrawn urineto be collected in the fluid receptacle.

The method 300 optionally includes, at 314, removing the urinecollecting apparatus from the penis of the user. Thus, the urinecollecting apparatus can capture and transport urine from a user withouthaving to attach a catheter to the urethral opening of the user's penis.In some implementations, the urine can flow against gravity duringcollection.

Finally, the method 300 optionally includes, at 316, disposing a secondurine collecting apparatus in operative relationship with the urethralopening of the user, with the head of the penis of the user disposedthrough the opening and into the cavity of the urine collectingapparatus.

FIG. 5 is a schematic block diagram of a system 400. The system 400includes an assembly 402. The assembly 402 includes a permeable membrane430, a permeable support 440, and an impermeable casing 450 (alsoreferred to herein as an “impermeable layer”). The permeable support 440and the impermeable casing 450 collectively define a reservoir 410 (alsoreferred to herein as a “chamber”). The assembly 402 also includes anoutlet 420 (also referred to herein as a “port”) in fluidiccommunication with the reservoir 410. The permeable support 440 and thepermeable membrane 430 can be arranged such that the permeable membrane430 defines a cavity 452 within the impermeable casing 450. Theimpermeable casing 450 defines an opening 432 such that the cavity 452is accessible from an exterior of the assembly 402. The impermeablecasing 450 can direct fluid toward the reservoir 410 and/or reduceand/or prevent fluid from exiting the assembly 402 except via the outlet420. In some implementations, the assembly 402 can be arranged such thata fluid can flow through the opening 432, into the cavity 452, throughthe permeable membrane 430, through the permeable support 440, into thereservoir 410, and out of the outlet 420. In some implementations, theassembly 402 can be arranged such that a user's penis can be insertedthrough the opening 432 such that the user's urethral opening isdisposed within the cavity 452 and a fluid can flow from the user'surethral opening, into the cavity 452, through the permeable membrane430, through the permeable support 440, into the reservoir 410, and outof the outlet 420. In some implementations, the system 400 can include adischarge line 422 (also referred to herein as a “received tube”). Thedischarge line 422 can be fluidically coupled to an external receptacle460. The external receptacle 460 can be in fluidic communication with avacuum source 470 via a vacuum line 424. The discharge line 422 and thevacuum line 424 can both include flexible tubing, such as, for example,flexible plastic tubing.

More specifically, the impermeable casing 450 can define an interiorregion accessible via the opening 432. The permeable membrane 430 andthe permeable support 440 can be disposed within the interior region ofthe impermeable casing 450. The impermeable casing 450 can be anysuitable shape. For example, in some implementations, the impermeablecasing 450 can be bowl-shaped. In some implementations, the impermeablecasing 450 can include a bottom surface and at least one sidewall. Insome implementations, the opening 432 can be opposite a bottom surfaceof the impermeable casing 450. In some implementations, the opening 432can be any suitable shape and/or size. In some implementations, theimpermeable casing 450 can optionally include a lip 456 such that theopening 432 is bounded and defined at least partially by the lip 456.The lip 456 can partially or completely surround the opening 432. Insome implementations, the lip 456 can be shaped and sized such that thelip 456 can reduce the potential of urine flowing out of the opening 432and/or such that the risk of splashing of urine through the opening 432is reduced.

In some implementations, the opening 432 has a width and/or lengthsimilar in size to the diameter of a user's penis. In someimplementations, the opening 432 is larger in width and/or length thanthe diameter than a user's penis. In some implementations, the opening432 can be, for example, circular or ovalular. In some implementations,the opening 432 can have any suitable shape. Similarly, the impermeablecasing 450 can have any suitable shape and/or perimeter shape, such asthe shape of, for example, an oblong, square, triangle, circle, oval, oran irregular shape. For example, the opening 432 (and the impermeablecasing 450) can have a rounded or semi-circular first portion and asecond portion that tapers from a first side adjacent to the firstportion having a first width to a second width smaller than the firstwidth. In some implementations, the shape of the opening 432 can be thesame or similar as the perimeter shape of the top of the impermeablecasing 450.

In some implementations, the permeable support 440 can have a bottomside with a periphery. The periphery can be secured to the impermeablecasing 450. In some implementations, the periphery can be secured (e.g.,via adhesive) to a portion of the impermeable casing 450 adjacent a topedge of the impermeable casing. In some implementations, the impermeablecasing 450 can extend upward beyond the location to which the peripheryof the permeable support 540 is attached. In some implementations, theimpermeable casing 450 can be attached to the permeable support 440 viaany suitable retention mechanism, such as, for example, retainer clipsor other fasteners. In some implementations, the permeable support 440and the permeable membrane 430 can be placed within the impermeablecasing without additional coupling mechanisms.

The impermeable layer 450 can be impermeable to fluid, such as, forexample, urine. In some implementations, the impermeable layer 450 canhave a fluid transportation function and can assist in directing fluidtowards the reservoir 410 and/or through the outlet 420 of the reservoir410. In some implementations, the impermeable layer 450 can be formed asan integral, unitary structure. In other implementations, theimpermeable layer 450 can be a multi-piece structure. The impermeablelayer 450 can be a pre-molded (e.g., injection or blow molded)component. Alternatively, the impermeable layer 450 can be formed of amaterial, such as elongate strips of an adhesive tape, wrapped around atleast a portion of the reservoir 410, a portion of the permeable support440, and/or a portion of the permeable membrane 430. In someembodiments, the impermeable layer 450 can be formed of cardboard,pressed paper, and/or coated paper. In some embodiments, the impermeablelayer 450 can be flexible.

The permeable membrane 430 can be formed of a material that haspermeable properties with respect to liquids such as urine. Thepermeable properties can be wicking, capillary action, diffusion, orother similar properties or processes, and are referred to herein as“permeable” and/or “wicking.” The permeable membrane 430 can have a highabsorptive rate and a high permeation rate such that urine can berapidly absorbed by the permeable membrane 430 and/or transportedthrough the permeable membrane 430. In some implementations, thepermeable membrane 430 can be flexible. In some implementations, thepermeable membrane 430 can be a ribbed knit fabric. In someimplementations, the permeable membrane 430 can include and/or have themoisture-wicking characteristic of gauze, felt, terrycloth, thick tissuepaper, and/or a paper towel. In some implementations, the permeablemembrane 430 can be soft and/or minimally abrasive such that thepermeable membrane 430 does not irritate the skin of the user. Thepermeable membrane 430 can be configured to wick fluid away from theurethral opening and/or the skin of the user such that the dampness ofthe skin of the user is lessened and infections are prevented.Additionally, the wicking properties of the permeable membrane 430 canhelp prevent urine from leaking or flowing beyond the assembly (e.g.,out of opening 432) onto, for example, a bed. In some implementations,the permeable membrane 430 can be formed of fine denier polyester fiberscoated with a thermoplastic water-based binder system. The tensilestrength can be, for example, about 45 lbs/inch² (measured using anInstron test method). The weight of a permeable membrane can be, forexample, about 12 grams (measured using the Mettler Gram Scale). Thethickness per ten permeable membranes can be, for example, about 2.5″(measured using the Gustin-Bacon/Measure-Matic).

The permeable support 440 can be positioned relative to the permeablemembrane 430 such that the permeable support 440 maintains the permeablemembrane 430 in a particular shape and allows for fluid, such as, forexample, urine, to flow through the permeable membrane 430, through thepermeable support 440, and into the reservoir 410. In someimplementations, the permeable membrane 430 can be disposed on a first,upper side of the permeable support 440, and the second, bottom side ofthe permeable support 440 can define a boundary of the reservoir 410. Insome implementations, the permeable support 440 can have a concave shapesuch that, when disposed within the impermeable casing 450, the cavity452 has a concave bottom. When the permeable membrane 430 is disposed onthe permeable support 440, the permeable membrane 430 can define aportion of the bottom and/or side boundaries of the cavity 452. When thepermeable support 440 and the permeable membrane 430 are disposed withinthe impermeable casing 450, the cavity 452 can be aligned with theopening 432 of the impermeable casing 450. The reservoir 410 can bedefined by the permeable support 440 and the impermeable casing 450 suchthat the reservoir 410 is concave and has any suitable shape and/ordimensions.

In some implementations, the permeable support 440 and/or the permeablemembrane 430 can be any suitable shape and/or size. In someimplementations, the permeable support 440 and the permeable membrane430 can have the same or similar shape and dimensions. In someimplementations, the permeable support 440 and/or the permeable membrane430 can be shaped such that the outer perimeter of the permeable support440 and/or the permeable membrane 430 can be the same or similar to theouter perimeter of the top of the impermeable casing 450 and/or theopening 432. In some implementations, the dimensions of the permeablesupport 440 and/or the permeable membrane 430 can be sized such that thecavity 452 can receive a penis of a user such that a head of the peniscan be partially or fully disposed within the cavity 452 (i.e., theshaft of the penis can be disposed within the opening 432 and the headof the penis can be fully disposed within the cavity 452, or theurethral opening of the head of the penis can be disposed within thecavity 452 and the head can be partially disposed within the cavity 452and partially outside the cavity 452, with the opening 432 surrounding aportion of the head). In some implementations, the cavity 452 can bedimensioned to receive a head of a penis of a user such that urine canbe received from the urethral opening of the penis within the cavity452, by the permeable membrane 430, and/or by the permeable support 440without urine splashing out of the opening 432.

In some implementations, the permeable support 440 can be configured tomaintain the permeable membrane 430 against the skin of a penis of auser and/or near a urethral opening of a user. For example, thepermeable support 440 can be shaped and sized such that the cavity 452is slightly larger than a head or tip of a penis of a user. Thepermeable support 440 can include a portion having a curved or convexshape in contact with the permeable membrane 430 such that the permeablemembrane 430 is also curved or convex. The permeable support 440 cansupport the permeable membrane 430 such that the permeable membrane 430can rest against the skin of the head or tip of the penis with theurethral opening directed toward a bottom surface of the impermeablecasing 450, and thus creating a comfortable and at least partiallyenclosed interface for engagement with the area of the body (e.g., thehead and/or neck of a penis of a user) near the urethral opening.

In some implementations, the permeable support 440 can be made of arigid plastic. In some implementations, the permeable support 440 canhave any suitable shape and be formed of any suitable material. Forexample, the permeable support 440 can be flexible. Additionally, thepermeable support 440 can be formed of aluminum, a composite of plasticand aluminum, some other metal and/or a composite of plastic and anothermetal. In some implementations, the permeable support 440 can be formedof a natural material, such as, for example, plant fibers (e.g., GreenerClean manufactured by 3M®). The natural material can include openingsthat allow fluid to flow through the natural material. In someembodiments, the permeable support 440 can be formed of perforatedcoated paper, such as tubular waxed paper.

The permeable support 440 can define one or more openings (e.g., anarray of openings) to allow for fluid flow from the permeable membrane430 to the reservoir 410. In some implementations, the permeable support440 can include membrane supports (e.g., struts) extending across anopening such that the opening is divided into an array of distinctslot-shaped openings. The membrane supports can be used to support thepermeable membrane 430. For example, the membrane supports can maintainthe shape of the permeable membrane 430 against the skin of a penis of auser and/or near a urethral opening of a user such that urine flowingfrom the urethral opening contacts and travels through the permeablemembrane 430. In some implementations, the permeable support 440 candefine several openings having a variety of shapes, such as a pluralityof round openings. In some implementations, the permeable support 440can be formed of spun plastic (e.g., non-woven permeable nylon andpolyester webbing) such that the permeable support 440 can have manyopenings. In some implementations, the permeable support 440 can beformed of a porous material. For example, the permeable support 440 canbe a porous glass container defining frits. In other implementations,the permeable support 440 can define an opening in the permeable support440 and the opening can be covered by a mesh screen defining manysmaller openings. In some embodiments, the reservoir 410 can include anyspaces and/or openings defined within the permeable support 440 (e.g.,spaces within porous material or defined within spun plastic material).

The reservoir 410 can be any suitable shape and/or have any diameter (orother dimension) suitable for receiving and transporting urine duringuse of the system 400. In some implementations, the reservoir 410 can besized such that the reservoir 410 is capable of collecting andtemporarily holding a large or small amount of urine until the urine canbe removed from the reservoir via the outlet 420. For example, thereservoir 410 can be sized such that the reservoir 410 is configured tohold a small amount of urine as may be released due to incontinence. Insome implementations, the reservoir 410 can be sized such that thereservoir 410 is configured to hold a large amount of urine as may bereleased during voiding of a full bladder. In some implementations, thereservoir 410 can be sized such that the reservoir is configured tocollect and hold a small or large amount of urine while the urine issimultaneously removed via, for example, gravity and/or a pump, such asthe vacuum source 470. Said another way, the reservoir 410 can functionas a sump and be sized such that the reservoir 410 can form a portion ofa passageway for urine from the permeable membrane 430, through thepermeable support 440, through the reservoir 410, and out of the outlet420. In a condition where the flow rate of urine into the assembly 402via the permeable membrane 430 is greater than the flow rate of urinethrough the discharge line 422, a temporary backup of urine may occur inthe reservoir 410. Thus, the reservoir 410 can be sized to contain avolume of fluid that may temporarily accumulate due to the difference inflow rates into and out of the assembly 402.

Although the outlet 420 is shown as extending from the side of thereservoir 410, in some implementations, the outlet 420 can extend fromthe bottom of the reservoir 410.

The external receptacle 460, via the discharge line 422, can collectfluid exiting the reservoir 410 through the outlet 420. The externalreceptacle 460 can be a sealed container. In some implementations, theexternal receptacle 460 can be disposable. In some implementations, theexternal receptacle 460 can be configured to be sterilized and reused.

In some implementations, gravity can cause fluid within the reservoir410 to follow a flow path (i.e., the fluid flow path including theoutlet 420 and the discharge line 422) from the reservoir 410 to theexternal receptacle 460. In some implementations, the vacuum source 470can assist and/or provide the pressure differential needed to draw fluidvoided from the urethral opening of a user into the permeable support440, into the reservoir 410, and from the reservoir 410 into theexternal receptacle 460. The vacuum source 470 can be fluidicallycoupled to the external receptacle 460 via a vacuum line 424 such thatgaseous fluid is drawn from the external receptacle 460 via the vacuumline 424. As a result of the decrease in pressure within the externalreceptacle 460 caused by the drawing of gaseous fluid out of theexternal receptacle 460, liquid and/or gaseous fluid can be drawn fromthe reservoir 410, through the outlet 420, through the discharge line422, and into the external receptacle 460. In some implementations, thevacuum source 470 can apply sufficient suction to capture all orsubstantially all of the urine voided by a user in a variety ofpositions (e.g., when a male user is lying on his side or back).

The vacuum source 470 can have a sufficiently high vacuum strength andair volume transport rate such that rapid air and liquid aspiration ismaintained over a portion of or the entire permeable membrane 430. Insome implementations, the one or more openings of the permeable support440 are distributed over an area that is slightly larger than the areaof the permeable membrane 430 that is configured to be wetted by urineflow in operation. Thus, the partial vacuum created by the vacuum source470 in combination with the one or more openings of the permeablesupport 440 and the permeable membrane 430 can draw the urine contactingthe permeable membrane 430 into the assembly 402 and, specifically, intothe reservoir 410. In some implementations, however, the one or moreopenings of the permeable support 440 should not be distributed over toolarge of an area of the permeable support 440 because the partial vacuumstrength may be reduced, thereby reducing the urine collection rate andthe efficiency of the system 400.

In some implementations, the vacuum source 470 can be the same orsimilar in structure and or function to the vacuum source 170 describedabove with respect to the system 100 shown in FIG. 1 . In someimplementations, urine collected by any of the systems and/or assembliesdescribed herein can be sampled for analysis using urine stripssimilarly as describe above with respect to the system 100 shown in FIG.1 . In some implementations, the external receptacle 460 can be the sameor similar in structure and/or function to the external receptacle 160described above with respect to the system 100 shown in FIG. 1 .

Although described as being intended for use by an adult male, in someimplementations the system 400 can be used in adult, pediatric, male,female, and veterinary applications for animals of different species andsizes. In female applications, the assembly 402 can be placed betweenthe legs or labia of the user and held snugly against the externalurethra by the pressure of friction from the user's body, by thepressure of the legs or by such means as an undergarment, elasticstrips, and/or adhesive tape. In male applications, the assembly 402 canbe placed such that a penis of a user is disposed within the assembly402 (e.g., within a cavity formed within the assembly 402). A male usercan use the assembly 402 in any suitable position, such as, for example,while lying on his back, lying on his side, sitting, or standing. Insome implementations, the head of the penis of the male user can beplaced in contact with the permeable membrane 430 during urination. Insome implementations, the head of the penis of the male user can bedisposed at least partially within the cavity 452, but not placed incontact with the permeable membrane 430 during urination.

FIG. 6 is a top view of an assembly 502. FIG. 7 is a cross-sectionalview of the assembly 502 taken along line 7-7 in FIG. 6 . The assembly502 includes a permeable membrane 530, a permeable support 540, and animpermeable casing 250 (also referred to herein as an “impermeablelayer”). The permeable membrane 530 and the permeable support 540 aredisposed within the impermeable casing 550. The permeable membrane 530,the permeable support 540, and the impermeable casing 550 can be thesame or similar in structure and/or function to the permeable membrane430, the permeable support 440, and the impermeable casing 450 describedabove with reference to the system 400. For example, the permeablesupport 540 and the impermeable casing 550 collectively define areservoir 510 (also referred to herein as a “chamber”). The impermeablecasing 550 defines an opening 532. The assembly 502 also includes anoutlet 520 (also referred to herein as a “port”) in fluidiccommunication with the reservoir 510.

The permeable support 540 and the permeable membrane 530 can be arrangedsuch that the impermeable membrane 550 and the permeable support 540and/or the permeable membrane 530 collectively define a cavity 552within the permeable membrane 530. The impermeable casing 550 can directfluid toward the reservoir 510 and/or reduce and/or prevent fluid fromexiting the assembly 502 except via the outlet 520. In someimplementations, the assembly 502 can be arranged such that a fluid canflow through the opening 532, into the cavity 552, through the permeablemembrane 530, through the permeable support 540, into the reservoir 510,and out of the outlet 520. In some implementations, the assembly 502 canbe arranged such that a user's penis can be inserted through the opening532 such that the user's urethral opening is disposed within the cavity552 and a fluid can flow from the user's urethral opening, into thecavity 552, through the permeable membrane 530, through the permeablesupport 540, into the reservoir 510, and out of the outlet 520. Adischarge line 522 (e.g., a tube) (also referred to herein as a“received tube”) can extend through the outlet 520. As shown in FIG. 7 ,a first end of the discharge line 522 can be positioned within thereservoir 510, and the discharge line 522 can extend through theimpermeable casing 550 such that fluid in the reservoir 510 can betransported away from the assembly 502 via the discharge line 522. Asecond end of the discharge line 522 can be fluidically coupled to anexternal receptacle (e.g., external receptacle 460). The externalreceptacle can be in fluidic communication with a vacuum source (e.g.,vacuum source 470) via a vacuum line (e.g., vacuum line 424). Thedischarge line 522 and the vacuum line can both include flexible tubing,such as, for example, flexible plastic tubing.

More specifically, the impermeable casing 550 can define an interiorregion accessible via the opening 532. The permeable membrane 530 andthe permeable support 540 can be disposed within the interior region ofthe impermeable casing 550. The impermeable casing 550 can be anysuitable shape. For example, in some implementations, the impermeablecasing 550 can be bowl-shaped. As shown in FIG. 7 , the impermeablecasing 550 can include a curved or concave bottom surface opposite theopening 532. As shown in FIGS. 6 and 7 , the impermeable casing 550 caninclude a lip 556 surrounding the opening 532. The lip 556 can definethe opening 532 such that the opening 532 is opposite the bottom surfaceof the impermeable casing 550 and the interior region of the impermeablecasing 550 is bounded (and collectively defined) by the curved orconcave bottom surface of the impermeable casing 550, the lip 556, andthe opening 532. The lip 556 can be shaped and sized such that the lip556 can reduce the potential of urine flowing out of the opening 532and/or such that the risk of splashing of urine through the opening 532is reduced. In some implementations, the opening 532 has a width and/orlength similar in size to the diameter of a user's penis. In someimplementations, the opening 532 is larger in width and/or length thanthe diameter than a user's penis. In some implementations, the opening532 can be irregularly shaped. For example, as shown in FIG. 6 , theopening 532 (and the impermeable casing 550) can have a rounded orsemi-circular first portion and a second portion that tapers from afirst side adjacent to the first portion having a first width to asecond width smaller than the first width.

As shown in FIG. 7 , the permeable support 540 can have a bottom sidewith a periphery 542. The periphery 542 can be secured (via, e.g.,adhesive) to an inner wall of the impermeable casing 550. In someimplementations, the periphery 542 can be secured at one or morelocations (or continuously along the periphery) such that the reservoir510 formed by the permeable support 540 and the impermeable casing 550is a suitable size for collecting and/or transporting urine, and suchthat the cavity 552 is sufficiently sized for a portion or all of auser's penis to be disposed within the cavity 552. In someimplementations, the impermeable casing 550 can be attached to thepermeable support 540 via any suitable retention mechanism, such as, forexample, retainer clips or other fasteners. In some implementations, thepermeable support 540 and the permeable membrane 530 can be placedwithin the impermeable casing without additional coupling mechanisms.

The impermeable layer 550 can be impermeable to fluid, such as, forexample, urine. In some implementations, the impermeable layer 550 canhave a fluid transportation function and can assist in directing fluidtowards the reservoir 510 and/or through the outlet 520 of the reservoir510. In some implementations, the impermeable layer 550 can be formed asan integral, unitary structure. In other implementations, theimpermeable layer 550 can be a multi-piece structure. The impermeablelayer 550 can be a pre-molded (e.g., injection or blow molded)component. Alternatively, the impermeable layer 550 can be formed of amaterial, such as elongate strips of an adhesive tape, wrapped around atleast a portion of the reservoir 510, a portion of the permeable support540, and/or a portion of the permeable membrane 530. In someembodiments, the impermeable layer 550 can be formed of cardboard,pressed paper, and/or coated paper. In some embodiments, the impermeablelayer 550 can be flexible.

The permeable membrane 530 can be formed of a material that haspermeable properties with respect to liquids such as urine. Thepermeable properties can be wicking, capillary action, diffusion, orother similar properties or processes, and are referred to herein as“permeable” and/or “wicking.” The permeable membrane 530 can have a highabsorptive rate and a high permeation rate such that urine can berapidly absorbed by the permeable membrane 530 and/or transportedthrough the permeable membrane 530. In some implementations, thepermeable membrane 530 can be flexible. In some implementations, thepermeable membrane 530 can be a ribbed knit fabric. In someimplementations, the permeable membrane 530 can include and/or have themoisture-wicking characteristic of gauze, felt, terrycloth, thick tissuepaper, and/or a paper towel. In some implementations, the permeablemembrane 530 can be soft and/or minimally abrasive such that thepermeable membrane 530 does not irritate the skin of the user. Thepermeable membrane 530 can be configured to wick fluid away from theurethral opening and/or the skin of the user such that the dampness ofthe skin of the user is lessened and infections are prevented.Additionally, the wicking properties of the permeable membrane 530 canhelp prevent urine from leaking or flowing beyond the assembly (e.g.,out of opening 532) onto, for example, a bed. In some implementations,the permeable membrane 530 can be formed of fine denier polyester fiberscoated with a thermoplastic water-based binder system. The tensile withthe Webb direction can be, for example, about 45 lbs/inch² measuredusing an Instron test method. The weight per permeable membrane can be,for example, about 12 grams measured using the Mettle Gram Scale. Thethickness per ten permeable membrane can be, for example, about 2.5″,measured using the Gustin-Bacon/Measure-Matic.

The permeable support 540 can be positioned relative to the permeablemembrane 530 such that the permeable support 540 maintains the permeablemembrane 530 in a particular shape and allows for fluid, such as, forexample, urine, to flow through the permeable membrane 530, through thepermeable support 540, and into the reservoir 510. In someimplementations, the permeable membrane 530 can be disposed on a first,upper side of the permeable support 540, and the second, bottom side ofthe permeable support 540 can define a boundary of the reservoir 510. Asshown in FIG. 7 , the permeable support 540 can have a concave shapesuch that, when the permeable membrane 530 is disposed on the permeablesupport 540 and the permeable membrane 530 and the permeable support 540are disposed within the impermeable casing 550, the cavity 552 has aconcave bottom. When the permeable support 540 and the permeablemembrane 530 are disposed within the impermeable casing 550, the cavity552 can be aligned with the opening 532 of the impermeable casing 550.The reservoir 510 can be defined by the permeable support 540 and theimpermeable casing 550 such that the reservoir 510 is concave and hasany suitable shape and/or dimensions.

In some implementations, the permeable support 540 and/or the permeablemembrane 530 can be any suitable shape and/or size. In someimplementations, the permeable support 540 and the permeable membrane530 can have the same or similar shape and dimensions. In someimplementations, the permeable support 540 and/or the permeable membrane530 can be shaped such that the outer perimeter of the permeable support540 and/or the permeable membrane 530 can be the same or similar to theouter perimeter of the top of the impermeable casing 550 and/or theopening 532. In some implementations, the dimensions of the permeablesupport 540 and/or the permeable membrane 530 can be sized such that thecavity 552 can receive a penis of a user such that a head of the peniscan be partially or fully disposed within the cavity 552 (i.e., theshaft of the penis can be disposed within the opening 532 and the headof the penis can be fully disposed within the cavity 552, or theurethral opening of the head of the penis can be disposed within thecavity 552 and the head can be partially disposed within the cavity 552and partially outside the cavity 552, with the opening 532 surrounding aportion of the head). In some implementations, the cavity 552 can bedimensioned to receive a head of a penis of a user such that urine canbe received from the urethral opening of the penis within the cavity552, by the permeable membrane 530, and/or by the permeable support 540without urine splashing out of the opening 532.

In some implementations, the permeable support 540 can be configured tomaintain the permeable membrane 530 against the skin of a penis of auser and/or near a urethral opening of a user. For example, thepermeable support 540 can be shaped and sized such that the cavity 552is slightly larger than a head or tip of a penis of a user. Thepermeable support 540 can include a portion having a curved or convexshape in contact with the permeable membrane 530 such that the permeablemembrane 530 is also curved or convex. The permeable support 540 cansupport the permeable membrane 530 such that the permeable membrane 530can rest against the skin of the head or tip of the penis with theurethral opening directed toward a bottom surface of the impermeablecasing 550, and thus creating a comfortable and at least partiallyenclosed interface for engagement with the area of the body (e.g., thehead and/or neck of a penis of a user) near the urethral opening.

In some implementations, the permeable support 540 can be made of arigid plastic. In some implementations, the permeable support 540 canhave any suitable shape and be formed of any suitable material. Forexample, the permeable support 540 can be flexible. Additionally, thepermeable support 540 can be formed of aluminum, a composite of plasticand aluminum, some other metal and/or a composite of plastic and anothermetal. In some implementations, the permeable support 540 can be formedof a natural material, such as, for example, plant fibers (e.g., GreenerClean manufactured by 3M®). The natural material can include openingsthat allow fluid to flow through the natural material. In someembodiments, the permeable support 540 can be formed of perforatedcoated paper, such as tubular waxed paper.

The permeable support 540 can define one or more openings (e.g., anarray of openings) to allow for fluid flow from the permeable membrane530 to the reservoir 510. In some implementations, the permeable support540 can include membrane supports (e.g., struts) extending across anopening such that the opening is divided into an array of distinctslot-shaped openings. The membrane supports can be used to support thepermeable membrane 530. For example, the membrane supports can maintainthe shape of the permeable membrane 530 against the skin of a penis of auser and/or near a urethral opening of a user such that urine flowingfrom the urethral opening contacts and travels through the permeablemembrane 530. In some implementations, the permeable support 540 candefine several openings having a variety of shapes, such as a pluralityof round openings. In some implementations, the permeable support 540can be formed of spun plastic (e.g., non-woven permeable nylon andpolyester webbing) such that the permeable support 540 can have manyopenings. In some implementations, the permeable support 540 can beformed of a porous material. For example, the permeable support 540 canbe a porous glass container defining frits. In other implementations,the permeable support 540 can define an opening in the permeable support540 and the opening can be covered by a mesh screen defining manysmaller openings. In some embodiments, the reservoir 510 can include anyspaces and/or openings defined within the permeable support 540 (e.g.,spaces within porous material or defined within spun plastic material).

The reservoir 510 can be any suitable shape and/or have any diameter (orother dimension) suitable for receiving and transporting urine duringuse of a system including assembly 502. In some implementations, thereservoir 510 can be sized such that the reservoir 510 is capable ofcollecting and temporarily holding a large or small amount of urineuntil the urine can be removed from the reservoir via the outlet 520.For example, the reservoir 510 can be sized such that the reservoir 510is configured to hold a small amount of urine as may be released due toincontinence. In some implementations, the reservoir 510 can be sizedsuch that the reservoir 510 is configured to hold a large amount ofurine as may be released during voiding of a full bladder. In someimplementations, the reservoir 510 can be sized such that the reservoiris configured to collect and hold a small or large amount of urine whilethe urine is simultaneously removed via, for example, gravity and/or apump, such as the vacuum source 570. Said another way, the reservoir 510can function as a sump and be sized such that the reservoir 510 can forma portion of a passageway for urine from the permeable membrane 530,through the permeable support 540, through the reservoir 510, and out ofthe outlet 520. In a condition where the flow rate of urine into theassembly 502 via the permeable membrane 530 is greater than the flowrate of urine through the discharge line 522, a temporary backup ofurine may occur in the reservoir 510. Thus, the reservoir 510 can besized to contain a volume of fluid that may temporarily accumulate dueto the difference in flow rates into and out of the assembly 502.

FIG. 8 is a flowchart illustrating a method of using an assembly tocollect urine from a user, according to an embodiment. The method 600optionally includes, at 602, fluidically coupling a discharge end of atube of a urine collecting apparatus to a fluid receptacle. The method600 optionally further includes, at 604, fluidically coupling thedischarge end of the tube of the urine collecting apparatus to a sourceof vacuum.

The method 600 further includes, at 606, disposing the urine collectingapparatus in operative relationship with the urethral opening of theuser, with a head of a penis of a male user (e.g. human or animal)disposed through an opening and into a cavity defined by a fluidpermeable membrane and a casing of the urine collecting apparatus. Theurine collecting apparatus can be the same or similar in structureand/or function to any of the urine collecting apparatus describedherein, such as, for example, the assembly 402 in FIG. 5 and/or theassembly 502 in FIGS. 6 and 7 . For example, the urine collectingapparatus can include a fluid impermeable casing, a fluid permeablesupport, a fluid permeable membrane, and a tube. The fluid impermeablecasing can define an opening, an interior region, and a fluid outlet.The fluid permeable support can have a first side and a second side. Thesecond side of the fluid permeable support and the fluid impermeablecasing can collectively define a reservoir. The fluid permeable supportcan also be disposed within the interior region of the fluid impermeablecasing. The fluid permeable membrane can be disposed on the first sideof the support and cover at least a portion of the support. The fluidpermeable membrane and the casing can collectively define the cavity.The tube can have a first end disposed in the elongated reservoir andextend through the fluid outlet to a second, fluid discharge end. Theassembly can be arranged such that a fluid can flow into the cavity fromthe urethral opening of the user's penis, flow through the fluidpermeable membrane and the fluid permeable support, collect in thereservoir, and flow out of the outlet.

The method 600 also includes, at 608, allowing urine discharged from thepenis to be received into the cavity, through the membrane, through thesupport, and into the reservoir.

The method 600 also includes, at 610, allowing the received urine to bewithdrawn from the reservoir via the tube and out of the fluid dischargeend of the tube.

The method 600 optionally includes, at 612, allowing the withdrawn urineto be collected in the fluid receptacle.

The method 600 optionally includes, at 614, removing the urinecollecting apparatus from the penis of the user. Thus, the urinecollecting apparatus can capture and transport urine from a user withouthaving to attach a catheter to the urethral opening of the user's penis.In some implementations, the urine can flow against gravity duringcollection.

Finally, the method 600 optionally includes, at 616, disposing a secondurine collecting apparatus in operative relationship with the urethralopening of the user, with the head of the penis of the user disposedthrough the opening and into the cavity of the urine collectingapparatus.

While various embodiments of the system, methods and devices have beendescribed above, it should be understood that they have been presentedby way of example only, and not limitation. Where methods and stepsdescribed above indicate certain events occurring in certain order,those of ordinary skill in the art having the benefit of this disclosurewould recognize that the ordering of certain steps may be modified andsuch modifications are in accordance with the variations of theinvention. Additionally, certain of the steps may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above. The embodiments have been particularlyshown and described, but it will be understood that various changes inform and details may be made.

For example, although various embodiments have been described as havingparticular features and/or combinations of components, other embodimentsare possible having any combination or sub-combination of any featuresand/or components from any of the embodiments described herein. Inaddition, the specific configurations of the various components can alsobe varied. For example, the size and specific shape of the variouscomponents can be different than the embodiments shown, while stillproviding the functions as described herein.

The invention claimed is:
 1. A urinary device assembly, comprising: a first assembly including: a first layer having a guide that at least partially extends about an opening disposed through a portion of the first layer; at least one second layer disposed in at least partial contact with the first layer; and a collector separate from and disposed between the first layer and the second layer in at least partial alignment with the opening, the collector at least partially defining an aperture and a completely enclosed channel in fluid communication with the opening and configured to receive fluid through the opening, wherein the channel includes an enclosed chamber within the collector and at least one of the channel or the collector form a circular or ovular ring; and a tube secured to the collector and in fluid communication with the aperture in the collector to direct the fluid away from the collector.
 2. The urinary device assembly of claim 1, wherein the guide includes a generally convex outer surface.
 3. The urinary device assembly of claim 1, wherein at least a portion of the guide is arced around the opening.
 4. The urinary device assembly of claim 1, wherein the first assembly is sized and dimensioned to be disposed between at least one of legs or labia of a female user over a urethral opening of the female user.
 5. The urinary device assembly of claim 4, wherein the opening is positioned on the first assembly to receive urine discharged from the urethral opening of the female user.
 6. The urinary device assembly of claim 1, wherein the tube includes a first end in fluid communication with the channel.
 7. The urinary device assembly of claim 1, wherein the collector in at least partial alignment with the opening at least partially overlaps with the opening.
 8. A urinary device assembly, comprising: a first assembly sized and dimensioned to be positioned between the legs of a female user over a urethral opening of the female user, the first assembly including: a first layer having a guide that at least partially extends about an opening disposed through a portion of the first layer; a second layer disposed in at least partial engagement with the first layer; and a collector separate from and disposed at least partially between the first layer and the second layer in at least partial alignment with the opening, the collector at least partially defining an aperture and a completely enclosed channel in fluid communication with the opening and configured to receive fluid through the opening, wherein the collector forms a circular or ovular ring; and a tube secured to the collector and in fluid communication with the aperture to direct fluid away from the collector.
 9. The urinary device assembly of claim 8, wherein the guide includes a generally convex outer surface.
 10. The urinary device assembly of claim 8, wherein at least a portion of the guide is arced around the opening.
 11. The urinary device assembly of claim 8, wherein the tube includes a first end in fluid communication with the channel of the collector.
 12. The urinary device assembly of claim 8, wherein the collector in at least partial alignment with the opening at least partially overlaps with the opening.
 13. The urinary device assembly of claim 8, further comprising: a fluid permeable layer disposed along a portion of the first layer over at least a portion of the opening; and a fabric layer that extends over the fluid permeable layer with the fluid permeable layer disposed between at least a portion of the first assembly and the fabric layer.
 14. A method of collecting urine from a female user, the method including: disposing a urine collecting assembly in operative relationship with a urethral opening of the female user with urine collecting assembly between legs of the female user; receiving urine discharged from the urethral opening through an opening in a first layer of the urine collecting assembly and into a completely enclosed channel at least partially defined by a collector of the urine collecting assembly, the collector including a circular or ovular ring having an aperture; and withdrawing the urine from the channel through the aperture in the circular or ovular ring via a tube secured to the collector.
 15. The method of claim 14, further comprising: fluidically coupling a fluid discharge end of the tube to a fluid receptacle; fluidically coupling the fluid discharge end of the tube to a source of vacuum to assist in withdrawing urine via the tube from a reservoir of the urine collecting apparatus; and collecting the urine withdrawn from the reservoir in the fluid receptacle.
 16. The method of claim 14, further comprising guiding the urine to the channel with a guide on the first layer that is arced around the opening of the first layer.
 17. The method of claim 14, further comprising securing the urine collecting assembly against the urethral opening of the female user with an undergarment worn by the female user. 